Effect of enobosarm on physical function in cancer patients with < or ≥ 5% weight loss in a phase IIb trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19585-e19585
Author(s):  
Shontelle Dodson ◽  
Mary Ann Johnston ◽  
Michael L. Hancock ◽  
Mitchell S. Steiner
Keyword(s):  
Weight Loss ◽  
Physical Function ◽  
Cancer Patients ◽  
Muscle Wasting ◽  
Early Stage ◽  
Lymphocytic Leukemia ◽  
Double Blind ◽  
Baseline Weight ◽  
Clinical Consequences ◽  
Multi Center Study

e19585 Background: Although cachexia has been defined as >5% weight loss, limited data exists on the prevention and treatment of muscle wasting prior to a patient becoming cachectic. Cancer induced muscle wasting can begin early in the course of a patient’s malignancy resulting in decline in physical function and other detrimental clinical consequences including less tolerability to chemotherapy, worse outcomes, and shorter survival - underscoring the importance of diagnosing and treating this condition at an early stage. Methods: We conducted a randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on physical function and muscle wasting in cancer patients. Subjects (n=159) were randomized to oral enobosarm or placebo for 16 weeks. Subjects were males >45y and postmenopausal females, with ≥2% weight loss in the 6 months prior to randomization and diagnosed with NSCLC, colorectal cancer, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or breast cancer. We report on changes in physical function based on weight loss of < or ≥5%in the 6 months prior to randomization. Results: 103 subjects (MITT) had physical function assessed by stair climb at baseline and week 16 with 24% losing <5% weight in the previous 6 months. Distribution of weight loss was similar across genders, however subjects with <5% weight loss were more likely to be ECOG=0 (<5% loss: 46.2%; ≥5% loss: 35.8%). Subjects with ≥5% weight loss had worse physical function at baseline compared to those with <5% loss (p=0.048). A significant improvement in physical function was observed in subjects that received enobosarm regardless of baseline weight loss (<5% loss, p=0.041, ≥5% loss, p<0.001) while subjects that received placebo failed to improve. Conclusions: Enobosarm was generally well tolerated and showed a statistically significant improvement in physical function in cancer subjects regardless of baseline weight loss. These data provide evidence that enobosarm may play an important role in the management of cancer patients by not only treating, but also preventing further decline in physical function and muscle wasting before a patient becomes cachectic.

Prevalence and impact of hypogonadism in cancer patients with severe muscle wasting in phase IIb enobosarm trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19582-e19582
Author(s):  
Mitchell S. Steiner ◽  
Adrian Dobs ◽  
Mary Ann Johnston ◽  
Michael L. Hancock ◽  
Ronald A. Morton ◽  
...  
Keyword(s):  
Weight Loss ◽  
Physical Function ◽  
Cancer Patients ◽  
Muscle Wasting ◽  
Controlled Trial ◽  
Performance Status ◽  
Lymphocytic Leukemia ◽  
Double Blind ◽  
Poor Outcomes ◽  
Multi Center Study

e19582 Background: Hypogonadism has been associated with weight loss and poor outcomes in cancer patients. Up to 50% of males with advanced cancer are hypogonadal at presentation or during the course of treatment. Wasting in cancer patients has also been associated with a decline in physical function and performance status and has major public health significance. We conducted a Phase IIb randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on muscle wasting and physical function in cancer patients. Methods: Patients (n=159) were randomized to oral enobosarm (1 or 3 mg) or placebo daily for 16 wks. Patients were males >45 y and postmenopausal females, had ≥2% weight loss in the 6 mths prior to randomization, BMI <35 and either NSCLC, colorectal cancer, non-Hodgkins lymphoma, chronic lymphocytic leukemia or breast cancer. We report on the incidence and impact of hypogonadism (T<300 ng/dL) in this population. Results: Baseline testosterone levels were available for 93 of 103 men. 60% of male patients were hypogonadal at randomization. Distribution of hypogonadism was similar across cancers; however hypogonadal men were less likely to complete the study. Baseline T levels were positively correlated with weight loss (r=0.32, p=0.002,) with hypogonadal men demonstrating greater weight loss in the previous six months (median, -9.5%). Baseline physical function as measured by stair climb power was higher among eugonadal males compared to hypogonadal males (84.5 watts vs 70.6 watts; p=0.016). Enobosarm significantly improved physical function in this population regardless of baseline gonadal status (hypogonadal: 18.7%, p=0.0061; eugonadal: 13.2%, p=0.0032). The magnitude of improvement was greater in hypogonadal men. Conclusions: Hypogonadism is common in male cancer patients and is correlated with weight loss and diminished physical function. In this randomized, placebo controlled trial, enobosarm improved physical function in both hypogonadal and eugonadal men despite poorer baseline physical function in hypogonadal patients. These data provide evidence that enobosarm may play an important role in the management of cancer related muscle wasting.

scholarly journals Malnutrition and cancer, diagnosis and treatment

2021 ◽  
Author(s):  
Angelika Beirer
Keyword(s):  
Weight Loss ◽  
Cancer Patients ◽  
Cancer Cachexia ◽  
Screening Tool ◽  
Psychological Treatment ◽  
Early Stage ◽  
Nutritional Therapy ◽  
German Society ◽  
Fat Free Mass ◽  
Nutritional Risk

Summary Background The prevalence of malnutrition in cancer patients ranges from about 20% to more than 70%. However, 10–20% of cancer patients’ deaths are related to malnutrition, not the malignancy itself. To reverse the pattern of weight loss, improve the patients’ quality of life, reduce the treatment toxicity, the psychological stress and the risk of mortality, the diagnosis of malnutrition should be made as early as possible to facilitate the best possible treatment. Methods A systematic literature search was conducted following guidelines of ESPEN (European Society for Clinical Nutrition), DGEM (German Society for Nutritional Medicine) and ASPEN (American Society for Parenteral and Enteral Nutrition). Results and conclusion To assess the risk of malnutrition, all cancer patients should be screened regularly with a valid screening tool (e.g., MUST [Malnutrition Universal Screening Tool], NRS [Nutritional Risk Screening] or PG-SGA [Scored Patient-Generated Subjective Global Assessment]). If risk of malnutrition is present, adequate nutritional therapy is recommended to stop involuntary weight loss. Patients should engage in exercise to maintain and improve muscle mass, strength and function. They should be offered regular dietetic counselling, and their muscle depletion should be monitored by determining fat-free mass. As cachectic patients in particular are at risk, the presence of cachexia should also be recognized at an early stage. Three consensus-based definitions are widely accepted: Fearon et al. and the EPCRC (European Palliative Care Research Collaborative) propose definitions specifically for cancer cachexia, while Evans et al. put forward a definition for cachexia associated with all types of underlying chronic diseases. However, if there is a cancer cachexia diagnosis, additional pharmacological and psychological treatment should be considered.

scholarly journals EFFICACY AND SAFETY OF STANDARDIZED CINNAMON BARK EXTRACT FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED WEIGHT LOSS AND ALOPECIA IN PATIENTS WITH BREAST CANCER: A RANDOMIZED, DOUBLE-BLIND, AND PLACEBO-CONTROLLED STUDY

2019 ◽  
pp. 163-168
Author(s):  
AJAY MEHTA ◽  
SUCHITRA MEHTA ◽  
PRASAD THAKURDESAI
Keyword(s):  
Breast Cancer ◽  
Weight Loss ◽  
Side Effects ◽  
Cancer Patients ◽  
Outcome Measures ◽  
Bark Extract ◽  
Efficacy And Safety ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Cinnamon Bark

Objective: The objective of the study was to evaluate the effects of IND02 (standardized Cinnamon bark extract) supplementation for the prevention of side effects of cancer chemotherapy in female patients with breast cancer. Methods: The study was conducted using double-blind, placebo-controlled design in 34 female breast cancer patients during the first 4 consecutive 21-day cycles of the standard chemotherapy regimen. The active treatment (IND02 capsules, 400 mg, one capsule, and thrice a day) or matching placebo was orally administrated in randomized (1:1 ratio) patients. The efficacy outcome measures were reduction in chemotherapy-induced weight loss, alopecia (hair fall), and other side effects. The safety outcome measures were hematology, ECG, vital signs, adverse event monitoring, and laboratory safety measurements. Results: The patients on the treatment with IND02 had shown significant protection from chemotherapy-induced severe weight loss (cachexia) and alopecia (reduced hair density and % hairs in the anagen phase, and increased % hairs in telogen phase) which was seen in the placebo group. IND02 treatment was found safe and well-tolerated during the study. Conclusion: Concomitant use of IND02 in breast cancer patients during breast cancer chemotherapy showed a clinical promise regarding efficacy and safety in preventing chemotherapy-induced weight loss and alopecia.

scholarly journals Weight Changes According to Treatment in a Diverse Cohort of Breast Cancer Patients

2021 ◽  
Author(s):  
Jami Fukui ◽  
Kami White ◽  
Timothy Frankland ◽  
Caryn Oshiro ◽  
Lynne Wilkens
Keyword(s):  
Breast Cancer ◽  
Weight Loss ◽  
Weight Gain ◽  
Cancer Patients ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Therapeutic Window ◽  
Breast Cancer Patients ◽  
Weight Changes ◽  
Time Points

Abstract BackgroundWeight changes are common among breast cancer patients. The majority of studies to date have focused on weight gain after a breast cancer diagnosis and its implications on health in survivors. Fewer studies have examined weight loss and its related characteristics. Weight changes have been reported to be influenced by several factors such as age, treatment, stage and pre-diagnostic weight. We evaluated weight changes during key treatment time points in early stage breast cancer patients.MethodsWe characterized 389 female patients diagnosed in Hawaii with early stage breast cancer from 2003-2017 in the Multiethnic Cohort (MEC) linked with Kaiser Permanente Hawaii electronic medical record data. We evaluated weight changes from surgery to 4 years post-diagnosis with six time points along a patient’s treatment trajectory (chemotherapy, radiation, endocrine, or surgery alone) and annually thereafter, adjusting for age, race/ethnicity and initial body mass index (BMI).ResultsWe found key time points of significant weight change for breast cancer patients according to their adjuvant treatment. In patients who had surgery alone (S), surgery-radiation (SR), or surgery-endocrine therapy (SE), the majority of patients had stable weight, although this consistently decreased over time. However, the percentages of patients with weight loss and weight gain during this time steadily increased up to 4 years after initial surgery. Weight loss was more common than weight gain by about 2 fold in these treatment groups. For patients with surgery-chemotherapy (SC), there was significant weight loss seen within the first 3 months after surgery, during the time when patients receive chemotherapy. And this weight loss persisted until year 4. Weight gain was less commonly seen in this treatment group.ConclusionsWe identified key time points during breast cancer treatment that may provide a therapeutic window to positively influence outcomes. Tailored weight management interventions should be utilized to promote overall health and long term survivorship.

scholarly journals Weight changes according to treatment in a diverse cohort of breast cancer patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12513-e12513
Author(s):  
Jami Aya Fukui ◽  
Kami White ◽  
Timothy Frankland ◽  
Caryn Oshiro ◽  
Lynne Wilkens
Keyword(s):  
Breast Cancer ◽  
Weight Loss ◽  
Weight Gain ◽  
Cancer Patients ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Therapeutic Window ◽  
Breast Cancer Patients ◽  
Weight Changes ◽  
Time Points

e12513 Background: Weight changes are common among breast cancer patients. The majority of studies to date have focused on weight gain after a breast cancer diagnosis and its implications on health in survivors. Fewer studies have examined weight loss and its related characteristics. Weight changes have been reported to be influenced by several factors such as age, treatment, stage and pre-diagnostic weight. We evaluated weight changes during key treatment time points in early stage breast cancer patients. Methods: We characterized 389 female patients diagnosed in Hawaii with early stage breast cancer from 2003-2017 in the Multiethnic Cohort (MEC) linked with Kaiser Permanente Hawaii electronic medical record data. We evaluated weight changes from surgery to 4 years post-diagnosis with six time points along a patient’s treatment trajectory (chemotherapy, radiation, endocrine, or surgery alone) and annually thereafter, adjusting for age, race/ethnicity and initial body mass index (BMI). Results: We found key time points of significant weight change for breast cancer patients according to their adjuvant treatment. In patients who had surgery alone (S), surgery-radiation (SR), or surgery-endocrine therapy (SE), the percentage of patients with stable weight, while generally comprising the majority, consistently decreased over time. However, the percentages of patients with weight loss and weight gain during this time steadily increased up to 4 years after initial surgery. Weight loss was more common than weight gain by about 2 fold in these treatment groups (weight loss 33.2%-42% vs weight gain 11.6%-21.4%). For patients with surgery-chemotherapy (SC), there was significant increase in patients with weight loss seen within the first 3 months after surgery (16.2% to 43.7%), during the time when patients receive chemotherapy. And this weight loss trend persisted until year 4. Weight gain was less commonly seen in this treatment group. Conclusions: We identified key time points during breast cancer treatment that may provide a therapeutic window to positively influence outcomes. Tailored weight management interventions should be utilized to promote overall health and long term survivorship.

Weight loss and muscle wasting in pediatric cancer patients undergoing radiotherapy

2021 ◽  
Vol 46 ◽  
pp. S706
Author(s):  
K.J.T. Guedes ◽  
R.L. Ferretti ◽  
T.L. Almeida ◽  
C.F. Marçon ◽  
M.Y.R.S. Moretti ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Muscle Wasting ◽  
Pediatric Cancer Patients

scholarly journals Evaluation of a protocol to detect malnutrition and provide nutritional care for cancer patients undergoing chemotherapy

2020 ◽  
Author(s):  
ELENA ÁLVARO SANZ ◽  
JIMENA ABILÉS ◽  
MARGARITA GARRIDO SILES ◽  
FRANCISCO RIVAS RUÍZ ◽  
BEGOÑA TORTAJADA GOITIA ◽  
...  
Keyword(s):  
Weight Loss ◽  
Weight Gain ◽  
Cancer Patients ◽  
Early Stage ◽  
Nutritional Intervention ◽  
Normal Weight ◽  
Nutritional Risk ◽  
Nutritional Interventions ◽  
Patients With Cancer ◽  
The Mean

Abstract Background Patients with cancer frequently experience malnutrition, which is associated with higher rates of morbidity and mortality. Therefore, the implementation of strategies for its early detection and for intervention should improve the evolution of these patients. Our study aim is to design and implement a protocol for outpatients starting chemotherapy, by means of which any malnutrition can be identified and treated at an early stage. Methods Before starting chemotherapy for patients with cancer, a complete assessment was made of their nutritional status, using the Nutriscore screening tool. When nutritional risk was detected, an interventional protocol was applied. Results Of 234 patients included in the study group, 84 (36%) required an individualised nutritional approach: 27 (32.1%) presented high nutritional risk, 12 had a Nutriscore result ≥ 5 and 45 experienced weight loss during chemotherapy. Among this population, the mean weight loss (with respect to normal weight) on inclusion in the study was − 3.6% ±8.2. By the end of the chemotherapy, the mean weight gain was 0% ±7.3 (p < 0.001) and 71.0% of the patients had experienced weight gain or maintenance, with respect to the initial weight. Conclusion More than a third of cancer patients who start chemotherapy are candidates for early nutritional intervention. This finding highlights the importance of early identification of patients at risk in order to improve the efficacy of nutritional interventions, regardless of the stage of the disease.

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